ClearPath DS-120 Clinical Study Protocol

Freedom Meditech ClearPath DS-120 Clinical Study Protocol FM2-002-CTP

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01425346

Enrollment

128

Registered

2011-08-30

Start date

2011-06-30

Completion date

2011-07-31

Last updated

2011-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ophthalmic, Healthy Eyes

Keywords

Ophthalmic, healthy eye, fluorescence, lens

Brief summary

The goal of this study is to measure lens fluorescence in normal subjects at various chronological ages that could serves as a guide to clinicians in determining changes in eye health. A measure of lens fluorescence can be used by clinicians as an indication of degenerative changes occurring in the lens of the eye.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Persons between the ages of twenty-one (21) and seventy (70). Best efforts shall be made to include as many patients as possible between the ages of thirty-five (35) and sixty (60). * Subject must be able to read or understand and give informed consent. * Pass the medical health history and comprehensive ophthalmic examination (which is determined by the investigator if the test subject has a normal ophthalmic examination and is in overall good health). Ophthalmic examination includes a clinical evaluation of the subject's eyes and a complete manifest refraction producing a best aided visual acuity of \<20/40.

Exclusion criteria

* Subject has had the crystalline lens removed from the study eye or has had the crystalline lens removed and replaced with an intraocular lens (IOL) implant in the left eye. * Subject has been clinically diagnosed with cataracts in the study eye. * Subject has had a fluorescence angiogram within the last six months. * Subject has undergone a treatment using photodynamic drugs within the last year. * Subject has Type I or II diabetes or is not deemed healthy from Demographic and Health Questionnaire or the comprehensive eye exam. * Subject was fit with contact lens within the last 30 days. * Subject has ocular surface (dry eye) disease. * Subject is unable to cooperate with or understand clinical instructions. * Subject is unable to complete test sequence

Design outcomes

Primary

Measure	Time frame	Description
Lens fluorescence	Day 1	evaluate the ability of the ClearPath DS-120 instrument to measure the fluorescence and scattering responses of the human crystalline lens in a normal subject population with healthy eyes (as determined by standard comprehensive ophthalmic examination).

Countries

United States

Outcome results